
The U.S. Food and Drug Administration is warning people to stop using certain types of glucose monitor sensors after the company that makes them, Abbott Diabetes Care, said the devices were linked to seven deaths and more than 700 injuries.
Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may provide incorrect low glucose readings, FDA officials said this week. Such readings over an extended period may lead people with diabetes to make bad treatment decisions, such as consuming too many carbohydrates or skipping or delaying doses of insulin.
“These decisions may pose serious health risks, including potential injury or death," the FDA said in the alert.
The sensors are devices that measure glucose levels in fluid just beneath the skin to provide real-time measurements of sugar in the blood. Information from the sensor is sent wirelessly to a device or phone.
The warning affects about three million sensors in the U.S. from a single production line, Abbott officials said in a statement. About half those devices have expired or been used, the company added. As of Nov. 14, the company reported seven deaths worldwide and 736 serious adverse events. No deaths occurred in the U.S., where 57 injuries were reported.
Abbott has notified all customers of the problem. The company said it has identified and resolved the issue in the affected production lot.
The FDA said people should stop using affected sensors and discard them.
The problem involved FreeStyle Libre 3 sensors with model numbers 72080-01 with unique device identifiers 00357599818005 and 00357599819002. It also involved FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 and unique device identifiers 00357599844011 and 00357599843014.
People can visit www.FreeStyleCheck.com to check if their sensors are potentially affected and request a replacement, the company said. No other FreeStyle Libre products are affected.
——
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
LATEST POSTS
- 1
Lula’s former human rights minister formally accused of sexual misconduct - 2
Winter storm warnings issued across Northeast as up to 9 inches of snow forecast; deadly atmospheric river in California snarls travel - 3
25 Years Ago, Audi's Rosemeyer Concept Was A Steampunk Supercar With A Massive Engine - 4
Iran begins cloud seeding to induce rain amid historic drought - 5
Mom finds out she has cancer after noticing something was off while breastfeeding
Vote in favor of your Number one Kind of Gems
Why this Iranian island looks like Mars after it rains
Northern lights chances rise for Christmas as space weather remains unsettled
2024's Savvy Home Gadgets for an Associated Way of life
Track down Your Optimal Conservative Vehicle: Famous Brands to Consider
Every year, she thanks the trooper for the arrest that led to her sobriety
White House responds to Sabrina Carpenter after pop star slams 'evil' ICE video using her song
Thousands of genomes reveal the wild wolf genes in most dogs’ DNA
Trump announces 'Patriot Games' with 2 competitors from every state and territory: What we know











